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Carboplatin, Ixabepilone, and Cetuximab in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Untreated With Chemotherapy

2012年3月5日 更新者:UNC Lineberger Comprehensive Cancer Center

A Phase II Trial of Carboplatin, Ixabepilone and Cetuximab in Chemotherapy Naive Advanced Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as carboplatin and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with monoclonal antibodies may be a better way to block cancer growth.

PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin and ixabepilone together with cetuximab works in treating patients with stage III or stage IV non-small cell lung cancer previously untreated with chemotherapy.

研究概览

详细说明

OBJECTIVES:

Primary

  • To estimate the disease-control rate in patients with advanced chemotherapy-naive non-small cell lung cancer after 2 courses of carboplatin, ixabepilone, and cetuximab.

Secondary

  • To estimate the progression-free survival of patients treated with this regimen.
  • To estimate the overall survival of patients treated with this regimen.
  • To estimate the toxicity of this regimen in these patients.
  • To determine the potential predictive marker of efficacy of ixabepilone and cetuximab. (exploratory)
  • To investigate the prevalence of cetuximab IgE antibody, and the rate of cetuximab hypersensitivity reactions in patients without evidence of cetuximab IgE antibodies.

OUTLINE: This is a multicenter study.

Patients receive carboplatin IV over 30 minutes and ixabepilone IV over 3 hours on day 1 and cetuximab IV over 1-2 hours on days 1, 8 and 15. Treatment repeats every 21 days for up to 2-4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.

Tumor tissue and blood samples are collected for further analysis.

After completion of study therapy, patients are followed periodically.

研究类型

介入性

阶段

  • 阶段2

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer

    • Chemotherapy-naive
    • Stage IIIB disease not amenable to surgery with pleural effusion, pericardial effusion, or not a candidate for chemoradiotherapy
    • Stage IV disease
  • Must have pathology block or unstained slides from initial or subsequent diagnosis

    • Diagnosis made via a core biopsy (not a fine-needle aspirate) required
  • Measurable disease as defined by RECIST guidelines

    • For patient who received prior radiotherapy, evaluable disease must be outside of the radiation field, or have new lesions that developed within the radiation field
  • Brain metastasis allowed provided it has been treated and determined to be controlled by the treating physician
  • No IgE cetuximab antibody

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Creatinine < 2.0 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of hepatic metastasis)
  • Bilirubin ≤ 1.5 times ULN
  • Prior malignancy allowed provided the treating physician determines that the patient's life expectancy is best defined by diagnosis of non-small cell lung cancer (NSCLC)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No peripheral neuropathy ≥ grade 2 by NCI CTCAE v. 3.0
  • No prior severe allergic reaction to any of the following:

    • Carboplatin
    • Taxane therapy
    • Monoclonal antibody
    • Hypersensitivity (NCI CTCAE grade3-4) to a drug formulated in Cremophor® EL (polyoxyethylated castor oil)
  • No active or uncontrolled infection
  • No significant history of uncontrolled cardiac disease including, but not limited to, any of the following:

    • Uncontrolled hypertension
    • Unstable angina
    • Myocardial infarction within the past 6 months
    • Uncontrolled congestive heart failure
    • Cardiomyopathy with decreased ejection fraction
  • No underlying interstitial lung disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 1 week since prior and no concurrent therapeutic radiotherapy

    • Palliative radiotherapy for painful bone lesions allowed
  • At least 6 months since prior adjuvant chemotherapy
  • No investigational agent(s) within the past 30 days
  • Not requiring concurrent treatment with any of the following:

    • Ketoconazole
    • Itraconazole
    • Ritonavir
    • Amprenavir
    • Indinavir
    • Nelfinavir
    • Delavirdine
    • Voriconazole
  • No other concurrent chemotherapy or cetuximab

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Disease-control rate after 2 courses of carboplatin, cetuximab, and ixabepilone
大体时间:42 days
Disease control rate will be defined as patients experiencing a complete or partial response or stable disease (radiographic response) measured by RECIST criteria.
42 days

次要结果测量

结果测量
措施说明
大体时间
Progression-free survival
大体时间:2 years
Radigoraphic response of measurable disease will be assessed using RECIST critera
2 years
Overall survival
大体时间:4 years
Radigoraphic response of measurable disease will be assessed using RECIST criteria
4 years
Number of subjects experiencing adverse events
大体时间:1 year
Adverse events will be assessed (graded) using CTCAE criteria
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年7月1日

初级完成 (实际的)

2009年11月1日

研究完成 (实际的)

2009年11月1日

研究注册日期

首次提交

2009年10月17日

首先提交符合 QC 标准的

2009年10月17日

首次发布 (估计)

2009年10月20日

研究记录更新

最后更新发布 (估计)

2012年3月6日

上次提交的符合 QC 标准的更新

2012年3月5日

最后验证

2012年3月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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